The following data is part of a premarket notification filed by Bd Biosciences with the FDA for Steller Cd61 Assay For Use On The Imagn 2000 Microvolume Fluorimeter.
| Device ID | K000611 |
| 510k Number | K000611 |
| Device Name: | STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER |
| Classification | Counter, Differential Cell |
| Applicant | BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Contact | Jo-ann E Fabila |
| Correspondent | Jo-ann E Fabila BD Biosciences 2350 QUME DR. San Jose, CA 95131 -1807 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-05-18 |